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ITFG/IPAC Collaboration Conclusion COMMITMENT OF THE ITFG/IPAC COLLABORATION More than 85 pharmaceutical scientists from more than 20 companies have been working diligently and constructively to address key concerns in draft CMC and BA/BE Guidance documents ITFG/IPAC is committed to collecting and assessing all relevant data available to the Collaboration, and sharing the findings in a timely fashion with the OINDP Subcommittee and the Agency ITFG/IPAC anticipates that this information will be useful to OINDP Subcommittee in its deliberations and the Agency in its preparation of final CMC and BA/BE Guidances that will benefit patients and the pharmaceutical industry

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ITFG/IPAC Collaboration Conclusion TIMEFRAME FOR TECHNICAL TEAM DELIVERABLES BA/BE Team : technical paper on BA/BE issues will be completed by June 30, 2000 Specifications Team: initial assessment of actual DCU & PSD capabilities of OINDP based on a statistical evaluation of the gathered database by July 31, 2000 Test and Methods Team : technical paper on key MDI tests will be completed in next 3-4 months Leachables/Extractables Team : technical reports will be written and recommendations made in next 3-4 months Supplier Quality Control Team : act as a co-leader in developing a cGMP guideline for component manufacturers with the Agency

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ITFG/IPAC Collaboration Conclusion NEED FOR A SCIENCE-BASED INTERACTIVE DIALOGUE The ITFG/IPAC Collaboration requests that the Agency: continue the OINDP Subcommittee process in order to resolve concerns about key CMC and BA/BE issues through a science-based interactive dialogue

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ITFG/IPAC Collaboration Conclusion ACKNOWLEDGEMENTS We express our gratitude to the Agency for holding this meeting and allowing us to present the work of the ITFG/IPAC Collaboration We thank the members of the OINDP Subcommittee for considering our comments and proposals We acknowledge the hard work, commitment and constructive collaboration of the numerous experts involved in the ITFG/IPAC Collaboration